WELKIN Product Advantage
· Sterile assurance;
· Full compliance with ASME BPE, ISPE, cGMP, EU, and FDA GMP standards
· Customized design reduces material residuals, increases yield, and lowers raw/auxiliary material consumption;
· Complete 3D plant model ensures EHS-compliant cleaning, operation, maintenance, and expansion, including utility/mechanical-electrical interfaces;
· Factory-built 1:1 modular systems with full functional testing accelerate delivery and reduce on-site installation/qualification time;
· Custom batch reports ‒ Comprehensive CIP/SIP/integrity/production records (with curves), auto-logging all parameters/steps, generating traceable batch reports (retrievable/printable);
· ISPE-based programming ‒ Modular control logic with recipe management, compliant with ISA88 and batch processing requirement
· Qualification services ‒ Full protocols (RA/RTM/VP/DQ/IQ/OQ) and PQ support
Application
· Liquid Dosage preparation and holding system
· Large Volume Parenteral (LVP)
· Small Volume Parenteral (SVP)
· Contrast agent
· Eye drop liquid
· Suspension solution
· Microsphere
· Nanoparticle and Fatty emulsion
· Spray aerosol
· Inhalant
· Oral liquid
Biopharmaceuticals Process Vessels system
·Media Preparation/holding system
·Feeding System
·Harvest system and elucidation system
·Sample loading and holding system in Purification process Buffer Preparation and holding system
·Bio-waste inactivation system
·CIP station
·Chemical Synthesis system
·Polypeptide synthesis process package system (synthesis, purification)
·Oligo synthesis process package system (synthesis, purification)
Keywords:
Welkin
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